공시 • May 20
Krystal Biotech, Inc. Announces United Kingdom Mhra Approval of Vyjuvek for the Treatment of Dystrophic Epidermolysis Bullosa Krystal Biotech, Inc. announced that, on May 15, 2026, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization to VYJUVEK (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth. VYJUVEK is the first genetic medicine approved in the United Kingdom for the treatment of DEB and is designed to address the root cause of the disease by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression with redosing. The approval in the United Kingdom also includes flexible administration options similar to those granted in the United States, European Union, and Japan, allowing for dosing at home or in a healthcare setting, with the option for administration by patients or their caregivers. VYJUVEK also fulfilled the United Kingdom Orphan Designation criteria and will be added to the Orphan Register held by the MHRA, allowing it to benefit from up to 12 years of market exclusivity. The approval of VYJUVEK by the MHRA was based on a comprehensive clinical dataset including results from the Company’s Phase 1/2 GEM-1 and Phase 3 GEM-3 studies, which collectively provided clear clinical evidence of successful COL7A1 gene delivery and durable wound closure following topical administration, and was further supported by results from the Company’s open label extension study and real-world experience with VYJUVEK. The timing for launch of VYJUVEK in the United Kingdom will depend on completion of reimbursement procedures currently underway. VYJUVEK was previously approved by the Food and Drug Administration in the United States in May 2023, the European Commission in April 2025, and Japan’s Ministry of Health, Labour and Welfare in July 2025. VYJUVEK is indicated for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth. Reported Earnings • May 05
First quarter 2026 earnings released: EPS: US$1.91 (vs US$1.24 in 1Q 2025) First quarter 2026 results: EPS: US$1.91 (up from US$1.24 in 1Q 2025). Revenue: US$116.4m (up 32% from 1Q 2025). Net income: US$55.9m (up 56% from 1Q 2025). Profit margin: 48% (up from 41% in 1Q 2025). The increase in margin was driven by higher revenue. Revenue is forecast to grow 20% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Europe. Board Change • May 04
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 4 highly experienced directors. Independent Director Catherine Mazzacco was the last director to join the board, commencing their role in 2023. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. 공시 • Apr 24
Krystal Biotech, Inc. to Report Q1, 2026 Results on May 04, 2026 Krystal Biotech, Inc. announced that they will report Q1, 2026 results Pre-Market on May 04, 2026 공시 • Apr 07
Krystal Biotech, Inc., Annual General Meeting, May 15, 2026 Krystal Biotech, Inc., Annual General Meeting, May 15, 2026. Board Change • Apr 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 4 highly experienced directors. Independent Director Catherine Mazzacco was the last director to join the board, commencing their role in 2023. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Reported Earnings • Feb 18
Full year 2025 earnings released: EPS: US$7.08 (vs US$3.12 in FY 2024) Full year 2025 results: EPS: US$7.08 (up from US$3.12 in FY 2024). Revenue: US$389.1m (up 34% from FY 2024). Net income: US$204.8m (up 130% from FY 2024). Profit margin: 53% (up from 31% in FY 2024). The increase in margin was primarily driven by higher revenue. Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Europe. New Risk • Jan 15
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Italian stocks, typically moving 5.2% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. This is currently the only risk that has been identified for the company. Valuation Update With 7 Day Price Move • Jan 14
Investor sentiment improves as stock rises 16% After last week's 16% share price gain to €251, the stock trades at a forward P/E ratio of 37x. Average trailing P/E is 16x in the Biotechs industry in Europe. Simply Wall St's valuation model estimates the intrinsic value at €486 per share. 공시 • Jan 09
Krystal Biotech Announces Positive Interim Clinical Update from KB407 Phase 1 Coral-1 Study with Confirmation of Wild-Type CFTR Delivery to the Lungs of Patients with Cystic Fibrosis Krystal Biotech, Inc. announced a positive interim clinical update from the highest dose cohort of CORAL-1, the Company's multi-center, dose escalation Phase 1 study evaluating KB407 in patients with cystic fibrosis (CF), confirming the successful lung delivery and expression of wild-type cystic fibrosis transmembrane conductance regulator (CFTR) protein following inhaled administration of KB407. 공시 • Jan 08
Krystal Biotech to Announce Interim Clinical Update from Highest Dose Cohort of Phase 1 CORAL-1 Study Evaluating KB407 in Patients with Cystic Fibrosis Krystal Biotech, Inc. announced that it will host an investor conference call and webcast on January 8, 2026, to disclose an interim clinical update from CORAL-1, the Company's multi-center, dose escalation Phase 1 study evaluating KB407 in patients with cystic fibrosis. The interim clinical update will focus on results from patients in the highest dose cohort of CORAL-1 and include molecular assessments of KB407 transduction and wild-type cystic fibrosis transmembrane conductance regulator (CFTR) protein expression following inhaled administration of KB407. Reported Earnings • Nov 04
Third quarter 2025 earnings released: EPS: US$2.74 (vs US$0.95 in 3Q 2024) Third quarter 2025 results: EPS: US$2.74 (up from US$0.95 in 3Q 2024). Revenue: US$97.8m (up 17% from 3Q 2024). Net income: US$79.4m (up 192% from 3Q 2024). Profit margin: 81% (up from 32% in 3Q 2024). The increase in margin was primarily driven by lower expenses. Revenue is forecast to grow 27% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Europe. 공시 • Oct 21
Krystal Biotech, Inc. to Report Q3, 2025 Results on Nov 03, 2025 Krystal Biotech, Inc. announced that they will report Q3, 2025 results at 9:30 AM, US Eastern Standard Time on Nov 03, 2025 공시 • Oct 15
Krystal Biotech, Inc. Receives FDA Platform Technology Designation for HSV-1 Viral Vector Used in KB801 for the Treatment of Neurotrophic Keratitis Krystal Biotech, Inc. announced that the United States Food and Drug Administration (FDA) granted platform technology designation to the genetically modified, non-replicating herpes simplex virus type 1 (HSV-1) viral vector used in the Company's redosable eye drop gene therapy KB801, currently under evaluation in a randomized placebo controlled trial for the treatment of neurotrophic keratitis (NK). The FDA's platform technology designation program is intended to provide efficiencies in drug development, manufacturing, and review processes for drug product applications that incorporate designated platform technologies. Potential benefits of the designation may include early and more frequent engagement with the FDA during clinical development as well as the opportunity to leverage manufacturing and nonclinical safety data from a prior product using the designated platform technology, such as VYJUVEK, in submissions to the FDA. The FDA may also consider previous inspectional findings related to the manufacture of a drug that incorporates the designated platform technology. To be eligible for a platform technology designation, a technology must be well-understanding and reproducible, used in an FDA-approved drug or biologic product, such as VYJ UVEK, have the potential to support the development of multiple drugs or biologic products without compromising quality, manufacturing, or safety, and have a reasonable likelihood to bring significant efficiencies to the development or manufacturing process as well as to the FDA review process. Drug product applications that are then recognized by the FDA to incorporate this technology may leverage the potential benefits of the designation. KB801 is a redosable eye drop gene treatment designed to enable sustained, localized expression and secretion of vein growth factor (NGF) by epithelial cells in the front of the eye for the treatment of NK, a rare,degenerative corneal disease that leads to corneal epithelial defects, ulcers, and perforation. Recombinant NGF eye drops have been shown to significantly improve corneal healing and are approved for the treatment of NK in multiple jurisdictions worldwide, but rapid clearance from the eye requires intensive administration six times a day, limiting therapeutic utility. By enabling the cells of the front of the eye to produce NGF locally, KB801 has the potential to significantly reduce the treatment burden for patients while also maintaining more consistent NGF levels in the front of the eye. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines in respiratory, oncology, dermatology, ophthalmology, and aesthetics. 공시 • Sep 16
Krystal Biotech Announces FDA Approval of Updated VYJUVEK Label Krystal Biotech, Inc. announced that the United States Food and Drug Administration (FDA) approved a label update for VYJUVEK®? (beremagene geperpavec-svdt) that expands the VYJUVEK eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients from birth and provides patients full flexibility with respect to VYJUVEK application and managing wound dressings. This label update is based on real-world data collected since VYJUVEK launch in the United States, as well as results from the open label extension study conducted in the United States and published earlier this year, which collectively reinforce the long-term safety and efficacy of VYJUVEK across patients of all ages, including in cases of patient or caregiver application. VYJUVEK is a non-invasive, topical, redosable genetic medicine designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds. VYJUVEk was designed to treat DEB at the molecular level by providing the patient's skin cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism. VYJUVE K is approved in the United States, Europe, and Japan. VYJUVE k gel may be applied by a healthcare provider, a caregiver, or the patient. After treatment, patients and caregivers should be careful not to touch treated wounds and dressings until the next dressing change.ash hands and wear protective gloves when changing wound dressings. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines in respiratory, oncology, dermatology, ophthalmology, and aesthetics. Reported Earnings • Aug 04
Second quarter 2025 earnings released: EPS: US$1.33 (vs US$0.54 in 2Q 2024) Second quarter 2025 results: EPS: US$1.33 (up from US$0.54 in 2Q 2024). Revenue: US$96.0m (up 37% from 2Q 2024). Net income: US$38.3m (up 146% from 2Q 2024). Profit margin: 40% (up from 22% in 2Q 2024). The increase in margin was driven by higher revenue. Revenue is forecast to grow 26% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Europe. 공시 • Jul 29
Krystal Biotech, Inc. to Report Q2, 2025 Results on Aug 04, 2025 Krystal Biotech, Inc. announced that they will report Q2, 2025 results Pre-Market on Aug 04, 2025 공시 • Jul 25
Krystal Biotech Announces Approval of VYJUVEK by Japan's Ministry of Health, Labour and Welfare for the Treatment of Dystrophic Epidermolysis Bullosa Krystal Biotech, Inc. announced that on July 24, 2025, Japan's Ministry of Health, Labour and Welfare (MHLW) granted marketing authorization to VYJUVEK (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB), starting from birth. VYJUVEK is the first genetic medicine approved in Japan for the treatment of DEB and is designed to address the root cause of the disease by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional type VII collagen protein expression with redosing. The Japanese approval allows for dosing at home or in a healthcare setting, with the option for administration by patients or their family members. As per the approval issued by the MHLW, VYJUveK is intended for use only in patients with a definite diagnosis of dystrophic epidermorysis bullosa. Genetic testing is not a requirement for treatment. VYJUVE K is the first genetic medicine approved In Japan for home administration after undergoing regulatory evaluation and environmental safety confirmation for type 1 use in accordance with the Cartagena Act. The timing for availability of VYJUVEK in Japan will depend on completion of reimbursement procedures currently underway. The Company currently expects to launch in Japan by the end of this year. The approval by Japan's MHLW was based on a comprehensive clinical dataset, which included results from an open label extension study conducted in Japanese patients. Results from the Japanese open label extension study closely mirrored prior clinical experience, including the Company's Phase 3 study in the United States, with all four patients that completed the study achieving the primary study endpoint of full wound closure at six months. VYJUVEk was also well tolerated and exhibited a safety profile in Japanese patients that was consistent with previous studies. The re- examination period for VYJUVEK In Japan is ten years. VYJUVEV was previously approved by the Food and Drug Administration in the United States in May 2023 and by the European Commission in April 2025. JAPAN INDICATION: Dystrophic epidermolytic bullosa. 공시 • Jul 09
Krystal Biotech Announces First Patient Dosed in Phase 1/2 Trial of Kb801 for the Treatment of Neurotrophic Keratitis Krystal Biotech, Inc. announced that the first patient has been dosed in its Phase 1/2 clinical trial ("EMERALD-1"), a 2:1 randomized, double-masked, multicenter, placebo-controlled study evaluating KB801 for the treatment of neurotrophic keratitis (NK). KB801 is a redosable eye drop gene therapy in development for the treatment of NK, a degenerative corneal disease characterized by damage or loss of function in the neurons innervating the eye leading to corneal
epithelial defects, ulcers, and perforation. Left untreated, NK can result in severe vision loss. Although NK is a rare disease with an estimated prevalence in the range of 10 to 50 cases per 100,000, claims data analyses suggest awareness and diagnosis rates are on the rise in the United States. Based on available claims data, an estimated 68,000 patients in the United States had a NK claim in 2024, up over 115% from 31,000 patients with a NK claim in 2020. EMERALD-1 is a randomized, double-masked, multicenter, placebo-controlled study evaluating KB801, administered as an eye drop, for the treatment of NK. Up to 27 adults with Stage 2 or Stage 3 NK, as defined by the Mackie criteria, will be enrolled and randomized 2:1 to receive either KB801, at a concentration of 1010 PFU/mL, or placebo topically to the study eye twice weekly for 8 weeks. The primary objective of EMERALD-1 is to evaluate the safety and tolerability of topical ocular administration of KB801 in patients with NK. The secondary objective is evaluation of efficacy based on the proportion of patients with complete durable healing of corneal epithelium at 8 weeks, defined as 0 mm corneal fluorescein staining in the area of the corneal lesion at both week 8 and 0 mm corneal fluorescein staining in the same area at week 10, as assessed by a masked reader. Additional exploratory efficacy measures will include change in corneal lesion size from baseline, each assessed at weeks 4, 6, 8, 10, and 20, as well as evaluations of corneal sensation and patient-reported symptom burden. More details of the EMERALD-1 study can be found at www.clinicaltrials.gov under NCT identifier NCT06999733. 공시 • Jun 25
Krystal Biotech Announces First Patient Dosed in Phase 3 Clinical Trial of Kb803 for the Treatment and Prevention of Corneal Abrasions in Patients with Dystrophic Epidermolysis Bullosa Krystal Biotech, Inc. announced that the first patient has been dosed in its Phase 3 clinical trial ("IOLITE"), an intra-patient, double-blind, multicenter, placebo-controlled study with crossover design evaluating KB803 for the treatment and prevention of corneal abrasions in dystrophic epidermolysis bullosa (DEB) patients. KB803 is designed to deliver two copies of the COL7A1 transgene to the corneal epithelium and enable local type VII collagen production in the front of the eye. IOLITE is an intra- patient, double-blind, placebo-controlled, multicenter Phase 3 study with a crossover design to evaluate KB803, administered as an eye drop, for the treatment and prevention of Corneal abrasions in DEB patients, 6 months of age or older. Patients seeking to participate in IOLITE must first enroll in the ongoing natural history study and complete a 12-week run-in period, during which they report the number of days that they experience symptoms of corneal abrasions. Subjects meeting the inclusion criteria following the 12-week run-in are eligible to participate in the IOLITE trial. The goal of therapy with KB803 is to address the fundamental disease-causing mechanism at the molecular level, by providing the patient's epithelial cells of the eye with the template to make normal type VII collagen locally. In a DEB patient treated under compassionate use with clinical observations reported the New England Journal of Medicine, regular eye drop administration was well tolerated with full corneal healing observed at three months, as well as significant visual acuity improvement from hand motion to 20/25 by eight months. 공시 • Jun 03
Krystal Biotech Presents Phase 1/2 Clinical Trial Results for Inhaled KB707 in Lung Cancer at ASCO 2025 On June 2, 2025, Krystal Biotech, Inc. provided a clinical update on the monotherapy cohort from its Phase 1/2 clinical trial of inhaled KB707 for the treatment of solid tumors of the lung, which was presented by Wen Wee Ma, MD, Enterprise Vice Chair, Research, Cancer Institute, Cleveland Clinic, in a poster entitled “Inhaled KB707, a Novel HSV-based Immunotherapy, as a Monotherapy in Patients with Advanced Solid Tumor Malignancies Affecting the Lungs: Efficacy and Safety Results from a Phase 1/2 Study” at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. 
